HIGHLIGHTS OF PRESCRIBING INFORMATION • Need to Evaluate for Comorbid Diagnoses: Re-evaluate if persists These highlights do not include all the information needed to use after 7 to 10 days of use. (5.3) AMBIEN safely and effectively. See full prescribing information for • Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and AMBIEN. anaphylaxis have been reported. Do not rechallenge if such reactions occur. AMBIEN® (zolpidem tartrate) tablets, for oral use, C-IV (5.4) Initial U.S. Approval: 1992 • Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been WARNING: COMPLEX BEHAVIORS reported. Immediately evaluate any new onset behavioral changes. (5.5) See full prescribing information for complete . • : Worsening of depression or suicidal thinking may occur. Complex sleep behaviors including sleep-walking, sleep-driving, and Prescribe the least amount of tablets feasible to avoid intentional overdose. engaging in other activities while not fully awake may occur (5.6) following use of AMBIEN. Some of these events may result in serious • Respiratory Depression: Consider this risk before prescribing in patients injuries, including death. Discontinue AMBIEN immediately if a with compromised respiratory function. (5.7) patient experiences a complex sleep behavior (4, 5.1). • Hepatic Impairment: Avoid AMBIEN use in patients with severe hepatic ------RECENT MAJOR CHANGES------­ impairment. (5.8) Boxed Warning 08/2019 • Withdrawal Effects: Symptoms may occur with rapid dose reduction or Contraindications (4) 08/2019 discontinuation. (5.9, 9.3) Warnings and Precautions, Complex Sleep Behaviors (5.1) 08/2019 ------ADVERSE REACTIONS------­ Warnings and Precautions, CNS- Effects and Next-Day Most commonly observed adverse reactions were: Impairment (5.2) 02/2019 Short-term (<10 nights): Drowsiness, dizziness, and diarrhea ------INDICATIONS AND USAGE------­ Long-term (28-35 nights): Dizziness and drugged feelings (6.1) AMBIEN, a gamma-aminobutyric acid (GABA) A receptor positive To report SUSPECTED ADVERSE REACTIONS, contact -aventis modulator, is indicated for the short-term treatment of insomnia characterized U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or by difficulties with sleep initiation. (1) www.fda.gov/medwatch. ------DOSAGE AND ADMINISTRATION------­ ------DRUG INTERACTIONS------­ • Use the lowest dose effective for the patient and must not exceed a total of • CNS , including : Possible adverse additive CNS- 10 mg daily (2.1) depressant effects (5.2, 7.1) • Recommended initial dose is a single dose of 5 mg for women and a single • Imipramine: Decreased alertness observed (7.1) dose of 5 or 10 mg for men, immediately before bedtime with at least 7-8 • : Impaired alertness and psychomotor performance hours remaining before the planned time of awakening (2.1) observed (7.1) • Geriatric patients and patients with mild to moderate hepatic impairment: • CYP3A4 inducers (rifampin or St. John’s wort): Combination use may Recommended dose is 5 mg for men and women (2.2) decrease effect (7.2) • Lower doses of CNS depressants may be necessary when taken • Ketoconazole: Combination use may increase effect (7.2) concomitantly with AMBIEN (2.3) • The effect of AMBIEN may be slowed if taken with or immediately after a ------USE IN SPECIFIC POPULATIONS------­ meal (2.4) • Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester. (8.1) ------DOSAGE FORMS AND STRENGTHS------­ • Lactation